South Africa: These 9 Drugs Face Patent Expirations and Generic Entry in 2025 - 2026

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: June 19, 2026
Generic Entry Controlled by: South Africa Patent 200,810,501

EMBEDA is a drug marketed by Alpharma Pharms. There are nine patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-four patent family members in twenty-three countries.

See drug price trends for EMBEDA.

The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. There are twenty-three drug master file entries for this API. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.

Generic name: betrixaban
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: December 08, 2026
Generic Entry Controlled by: South Africa Patent 200,904,758

BEVYXXA is a drug marketed by Portola Pharms Inc. There are five patents protecting this drug.

This drug has sixty-seven patent family members in twenty-six countries. There has been litigation on patents covering BEVYXXA

See drug price trends for BEVYXXA.

The generic ingredient in BEVYXXA is betrixaban. Additional details are available on the betrixaban profile page.

Generic name: pirfenidone
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: September 22, 2026
Generic Entry Controlled by: South Africa Patent 200,802,237

ESBRIET is a drug marketed by Genentech Inc. There are twenty patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has two hundred and sixty-six patent family members in forty-six countries. There has been litigation on patents covering ESBRIET

See drug price trends for ESBRIET.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this API. Twenty-four suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

Generic name: alcaftadine
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: March 31, 2026
Generic Entry Controlled by: South Africa Patent 200,809,327

LASTACAFT is a drug marketed by Abbvie. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in thirty countries. There has been litigation on patents covering LASTACAFT

See drug price trends for LASTACAFT.

The generic ingredient in LASTACAFT is alcaftadine. There are six drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the alcaftadine profile page.

Generic name: macitentan
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: August 29, 2026
Generic Entry Controlled by: South Africa Patent 200,902,164

OPSUMIT is a drug marketed by Actelion. There are five patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has ninety-nine patent family members in thirty-four countries. There has been litigation on patents covering OPSUMIT

See drug price trends for OPSUMIT.

The generic ingredient in OPSUMIT is macitentan. There are ten drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the macitentan profile page.

Generic name: linagliptin
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: May 04, 2026
Generic Entry Controlled by: South Africa Patent 200,808,361

TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

Generic name: difelikefalin acetate
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: November 10, 2026
Generic Entry Controlled by: South Africa Patent 200,903,053

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

Generic name: difelikefalin acetate
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: November 10, 2026
Generic Entry Controlled by: South Africa Patent 200,903,054

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

Generic name: telotristat etiprate
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: December 12, 2026
Generic Entry Controlled by: South Africa Patent 200,903,367

XERMELO is a drug marketed by Tersera. There are five patents protecting this drug.

This drug has seventy patent family members in twenty-nine countries.

See drug price trends for XERMELO.

The generic ingredient in XERMELO is telotristat etiprate. One supplier is listed for this generic product. Additional details are available on the telotristat etiprate profile page.

Generic name: macitentan; tadalafil
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: August 29, 2026
Generic Entry Controlled by: South Africa Patent 200,902,164

OPSYNVI is a drug marketed by Actelion. There are three patents protecting this drug.

This drug has ninety-nine patent family members in thirty-four countries. There has been litigation on patents covering OPSYNVI

See drug price trends for OPSYNVI.

The generic ingredient in OPSYNVI is macitentan; tadalafil. There are ten drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the macitentan; tadalafil profile page.